Multi-Center ASPIRE 1-Year Study Results Show
Healthcare Consumption Events are Significantly Lower after SURE
with CVAC System Compared to Standard URS
ASPIRE Study and Additional CVAC System Data
Presented at the 41st World Congress of Endourology and
Uro-Technology (WCET)
Calyxo, Inc., a medical device company developing innovative
solutions for patients with kidney stones, announces positive new
study results for its CVAC System in kidney stone clearance. The
new data show that healthcare consumption (HC) events including
emergency department (ED) visits, hospitalization and retreatment
were significantly lower after steerable ureteroscopic renal
evacuation (SURE) with the CVAC System compared to ureteroscopy
(URS). The new 1-year multi-center ASPIRE study results, along with
other key CVAC System data, were presented at the 41st World
Congress of Endourology and Uro-Technology (WCET) in Seoul, South
Korea, August 12-16, 2024.
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CVAC System (Photo: Business Wire)
“The ASPIRE 1-year data shows significantly lower cumulative
incidence of HC events after SURE compared to standard URS,” said
Dr. Karen L. Stern, urologist at the Mayo Clinic Arizona and
presenter of the study results. “This new data suggests that the
new CVAC System may have the potential for a positive clinical and
health economic impact in the treatment of urolithiasis,” she
added.
The treatment of kidney stones in the United States continues to
be a growing challenge with its prevalence increasing from 3.8% in
the late 1970s to 11% in 2021.1 In addition, studies have reported
that an estimated 23% of patients needed retreatment during the
first year following URS.2
The SURE procedure is exclusively performed with the CVAC System
and is the only complete stone clearance solution that enables
effective and efficient kidney stone removal. It is an all-in-one
system that integrates ureteroscopy, laser lithotripsy, irrigation,
aspiration, and stone collection.
The multi-center ASPIRE study is a prospective, randomized study
comparing the safety and efficacy of the SURE approach with the
CVAC System vs standard URS with basketing in 123 patients.
At 12 months, the ASPIRE study showed that HC events are
significantly lower after SURE compared to URS:
- 123 subjects were randomized and 101 qualified for the efficacy
analysis (SURE 46 vs URS 55).
- The 12-month subject retention was 95%.
- At 1-year, the cumulative incidence of HC events was
significantly lower for SURE versus URS (3 HC events in 2 subjects
vs 14 HC events in 9 subjects, p=0.015).
- Kaplan-Meier analysis demonstrated that by 12 months, 95.6% of
SURE subjects were free of HC events versus 83.5% for URS
subjects.
Additional data presented at WCET showed:
Initial Experience with the Second
Generation CVAC Aspiration System; Outcomes of Multi- Center Market
Research – Dr. Brian Eisner, Massachusetts General Hospital,
Harvard Medical School)
In this initial case experience, 50
urologists from 23 academic and private institutions completed 174
SURE procedures with the new CVAC System. The median stone burden
was 15 mm with no stone burden limit in the study. They found the
new-generation CVAC System achieved high stone clearance per
intraoperative visual assessment (81% of cases demonstrated
>95% stone clearance rate) with
improved ease of use. Top performance attributes included passive
aspiration of dust during laser lithotripsy, active aspiration of
larger fragments, direct visualization, and all-in-one capability
of the system.
Safety and Feasibility of the Steerable
Ureteroscopic Renal Evacuation Device, A Single Center Experience –
Dr. Luke Griffiths, Smith Institute for Urology, Northwell
Health
Single center retrospective chart review of
all patients (n=91) who underwent SURE January 2022 through August
2023. The study showed that SURE with the CVAC System is a safe and
effective treatment option for patients undergoing URS with high
stone free rate comparable to URS alone. In addition, SURE with the
CVAC System was associated with low morbidity even with treating
large volume stone disease.
Case presentation of the new CVAC System:
Is it going to change the game?!
A video case with Dr. Isaac Palma-Zamora, UT
Southwestern Medical Center will also be featured during WCET on
Wednesday, August 14, 2024, starting at 14:00.
“These important results presented during WCET further advance
and confirm earlier data showing that the SURE approach with the
CVAC System is safe and provides better stone clearance compared to
standard URS,” said Joe Catanese, PhD, Calyxo’s President &
CEO. “We are continuing to work with urologists, endourologists and
the healthcare community to raise awareness about our new
FDA-cleared CVAC System and how it can help improve outcomes for
patients with kidney stones,” he added.
For more information about the newly FDA-cleared CVAC System,
please visit: Calyxo, Inc.
About the CVAC System
The new CVAC System was recently FDA-cleared and enables a
minimally invasive approach for kidney stone clearance. It is an
all-in-one solution that is designed to efficiently and effectively
remove kidney stones. It uses irrigation and vacuum aspiration to
continuously clear stone fragments during and after laser
lithotripsy, enabling physicians to achieve a stone-free
outcome.
About Calyxo, Inc.
Calyxo, Inc. is an innovation-driven medical device company
focused on improving care for patients with kidney stones by
delivering paradigm-shifting solutions that enable urologists to
safely, effectively and efficiently achieve unrivaled clinical
outcomes. Learn more at calyxoinc.com.
FOR MORE INFORMATION:
Study investigators and presenters are available to discuss
further. For more information and to schedule interviews, please
contact: Alyssa Paldo Alyssa.paldo@finnpartners.com M: +1 847 791
8085
1 Kidney stones. National Kidney Foundation. (2024, July 22).
https://www.kidney.org/atoz/content/kidneystones 2 Johnston SS,
Chen BP, Rai P, Grange P, Dwarakanathan HR, Amos T, Johnson BH,
Ghosh SK, Buchholz N. Incremental Healthcare Cost Implications of
Retreatment Following Ureteroscopy or Percutaneous Nephrolithotomy
for Upper Urinary Tract Stones: A Population-Based Study of
Commercially-Insured US Adults. Med Devices (Auckl). 2022 Nov
10;15:371-384. doi: 10.2147/MDER.S384823. PMID: 36389203; PMCID:
PMC9662022.
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Alyssa Paldo Alyssa.paldo@finnpartners.com M: +1 847 791
8085